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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K260620

510(k) cleared

SeptAlign (SPLN001)

Spirair, Inc. · Jul 30, 2026 · K260620

FDA cleared the SeptAlign (SPLN001) from Spirair, Inc. on Jul 30, 2026 under K260620, a traditional 510(k). The device falls under product code NHB, Polymer, Ear, Nose And Throat, Synthetic, Absorbable, regulated at 21 CFR 874.3620 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Feb 25, 2026. The decision came 155 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spirair, Inc. has one other decision in the tracker over the last 12 months: K251790 (SeptAlign).

Questions & Answers

What did FDA clear under K260620?

K260620 is the FDA 510(k) for SeptAlign (SPLN001), submitted by Spirair, Inc.. FDA's decision date was Jul 30, 2026, under product code NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable).

Who makes the SeptAlign (SPLN001)?

Spirair, Inc., based in South San Francisco, Ca, is the applicant of record for K260620.

How long did the K260620 review take?

FDA received the submission on Feb 25, 2026 and issued its decision on Jul 30, 2026, 155 days later.

← All decisions in July 2026

Sources